Flexible implant with adjustable coils

ABSTRACT

Devices and methods for securing a graft with respect to bone are provided. One exemplary embodiment of a surgical implant includes a flexible filament body and a suture filament or repair construct that extends through the filament body at multiple locations. The repair construct is formed into one or more coils, which can receive a graft. The flexible filament body can be configured to be actuated between unstressed and anchoring configurations, the latter of which sets a location of the suture filament, and associated graft, in a bone tunnel. More particularly, the flexible filament body can ball up, or become denser, to a size that cannot pass into the bone tunnel in which the suture filament holding the graft is disposed. The present disclosure also provides for feedback units to assist a surgeon in knowing a location of the implant. Further, other exemplary devices and methods are provided.

FIELD

The present disclosure relates to devices and methods for securing softtissue to bone, and more particularly relates to using flexibleimplantable bodies in conjunction with a suture filament or repairconstruct formed to have adjustable coils for use in maintaining alocation of a graft with respect to a bone.

BACKGROUND

Joint injuries may commonly result in the complete or partial detachmentof ligaments, tendons, and soft tissues from bone. Tissue detachment mayoccur in many ways, e.g., as the result of an accident such as a fall,overexertion during a work related activity, during the course of anathletic event, or in any one of many other situations and/oractivities. These types of injuries are generally the result of excessstress or extraordinary forces being placed upon the tissues.

In the case of a partial detachment, commonly referred to under thegeneral term “sprain,” the injury frequently heals without medicalintervention, the patient rests, and care is taken not to expose theinjury to undue strenuous activities during the healing process. If,however, the ligament or tendon is completely detached from itsattachment site on an associated bone or bones, or if it is severed asthe result of a traumatic injury, surgical intervention may be necessaryto restore full function to the injured joint. A number of conventionalsurgical procedures exist for re-attaching such tendons and ligaments tobone.

One such procedure involves forming aligned femoral and tibial tunnelsin a knee to repair a damaged anterior cruciate ligament (“ACL”). In oneACL repair procedure, a ligament graft is associated with a surgicalimplant and secured to the femur. A common ACL femoral fixation meansincludes an elongate, hard, metallic “button,” sometimes referred to asa cortical button, having one or more filaments coupled to it. The oneor more filaments can be formed into one or more coils or loops sized toreceive the ligament graft(s) and allow an adequate length of thegraft(s) to lie within the femoral tunnel while providing secureextra-cortical fixation. During procedures that use cortical buttons,the button is typically flipped after it passed through and out of thebone tunnel (e.g., a femoral tunnel) so that the button lies flat on acortical surface while keeping the loop(s), and thus the graft(s)associated with the loop(s), in the tunnel. When flipping the button,however, the button can impinge on soft tissue disposed between thebutton and the bone, which can prevent the button from seating properlyon the cortical surface and damage the impinged tissue. Further, it canbe difficult to know when to “flip” the button. Current solutions tothis problem are to measure a length of the bone tunnel and mark thefilament associated with the button to indicate to the surgeon when thebutton is to be flipped, or providing a large enough opening to disposea visualization device, like an endoscope or laparoscope, at thesurgical site to see when the button exits the tunnel and can beflipped.

Another drawback to present devices and methods is that the bone tunnelsthrough which an implant such as a cortical button, and the associatedfilament(s) and graft(s), pass can often be relatively large toaccommodate the size of the implant and the graft(s) at various pointsduring the procedure. A procedure for forming a bone tunnel, such as afemoral tunnel, through which the implant is passed and in which thegraft(s) is disposed is illustrated in FIGS. 1A-1D. A bone 100 in whicha tunnel 101 (FIG. 1D) is to be formed is illustrated in FIG. 1A. Theprocedure begins by using a Beath pin to form an initial guide tunnel102 through an entire thickness of the bone 100, as shown in FIG. 1B,the tunnel 102 having a diameter approximately in the range of about 2millimeters to about 2.5 millimeters. The Beath pin, which is typicallythin and long, can remain disposed within the initial guide tunnel 102to act as a guidewire to help position additional tools for drillingportions of the tunnel 101 having a larger diameter.

A reamer can be passed over the Beath pin to form a larger, passingtunnel 104 through an entire thickness of the bone 100, as shown in FIG.1C. The previously formed initial guide tunnel 102 is illustrated inFIG. 1C using a dotted line to provide context of a diameter of thepassing tunnel 104 as compared to a diameter of the initial guide tunnel102. The diameter of the initial guide tunnel 102 is typically too smallto have a typical cortical button passed through it, which is why thepassing tunnel 104 is formed. A diameter of the passing tunnel 104 canbe driven by the size of the width of the cortical button, and thus canbe approximately in the range of about 4 millimeters to about 5millimeters. A portion of the tunnel 101, as shown in FIG. 1D a distalportion 101 d that is formed into a graft tunnel 106, can then befurther expanded and sized for having one or more grafts disposed in it.A reamer can be used to form the graft tunnel 106. The previously formedinitial guide and passing tunnels 102, 104 are illustrated in FIG. 1Dusing dotted lines to provide context of a diameter of the graft tunnel106 as compared to diameters of the initial guide and passing tunnels102, 104. A diameter of the graft tunnel 106 can be based on the size ofthe graft(s) to be disposed therein, and can be approximately in therange of about 6 millimeters to about 8 millimeters.

Accordingly, it is desirable to have implantable bodies that aredesigned to sit more consistently and favorably with respect to thecortical surface and not impinge tissue disposed between the body andthe bone. It is also desirable to have devices and methods that aredesigned to limit the number of steps used to form bone tunnels in whichthe implant(s) and graft(s) are disposed, avoids having to measure andmark components of the implant to assist in visualizing a location ofthe implant(s), and/or limits the amount of bone removed when formingbone tunnels into which the implants and grafts are passed and/ordisposed.

SUMMARY

Devices and methods are generally provided for performing soft tissue(e.g., ACL) repairs. The devices and methods use flexible and/or softbodies as the implant or body that ultimately rests against the corticalbone, in conjunction with filament formed into one or more loops orcoils to maintain a location of a graft(s) with respect to the flexibleand/or soft body, and thus the bone against which the body rests. Thedesigns of the devices and methods provided for in the presentdisclosure allow for portions of the bone tunnels through which only theimplant and not the graft(s) pass to be smaller when compared toexisting techniques, and also reduce the possibility of the implant notsitting properly against the cortical bone and/or impinging tissuebetween the implant and the bone. Additionally, mechanisms forcommunicating to a surgeon that the flexible and/or soft body has passedthrough a bone tunnel and can be actuated to set the location of theimplant with respect to the bone are also provided. As a result, many ofthe disclosures provided for herein make it so visualization techniquessuch as measuring bone tunnels and marking implants, filaments, and/orgrafts are no longer necessary.

In one exemplary embodiment, a surgical implant includes a flexiblefilament body and a suture filament extending through the flexiblefilament body at two or more separate locations on the flexible filamentbody to form one or more coils. The configuration is such that a portionof each coil is disposed on a top side of the body and a portion of eachcoil is disposed on a bottom side of the body, with each coil definingan opening for that coil. The suture filament includes a slidableportion formed from the filament. Movement of the slidable portiontoward and away from the flexible filament body causes a size of atleast one opening of the one or more coils to change. A first and asecond location at which the suture filament extends through theflexible filament body are located on opposed sides of the flexiblefilament body from each other along a length of the flexible filamentbody with the slidable portion of the suture filament being disposedtherebetween. For example, the first location can be disposed on oneside along a length of the body, the second location can be disposed ona second, opposed side along the length of the body, and the slidableportion of the suture filament can be disposed between the first andsecond locations, e.g., approximately at a midpoint along the length ofthe body. The flexible filament body and the suture filament areconfigured so application of tension to the one or more coils in adirection away from the flexible filament body causes the flexiblefilament body to constrict such that the first and second locations onthe flexible filament body are located closer together than they wereprior to the flexible filament body constricting when the flexiblefilament body is extended along its length.

A tensioning tail can extend from the slidable portion of the suturefilament. The tail can be configured to move the slidable portion tochange the size of the at least opening of the one or more coils. Insome embodiments, the tensioning tail is formed from the suturefilament. In such instances, the sliding portion can include a slidableknot that is slidably adjustable by applying tension to the tensioningtail. Further, the slidable knot can be a self-locking knot.

A distance extending between terminal, lengthwise ends of the flexiblefilament body as measured prior to being constricted can be greater thana distance extending between terminal, lengthwise ends of the flexiblefilament body as measured after the flexible filament body isconstricted. The suture filament can include a hollow portion, and asliding portion can include a portion of the suture filament disposedwithin the hollow portion. In such embodiments, the portion of thesuture filament disposed within the hollow portion can be adjusted byapplying tension to the tensioning tail. Further, the suture filamentcan also include a second hollow portion and a second sliding portion,with the second sliding portion including a portion of the suturefilament disposed within the second hollow portion. In such embodiments,the portion of the suture filament disposed within the second hollowportion can be adjusted by applying tension to a second tensioning tailformed from the suture filament. The second tensioning tail can extendfrom the second sliding portion and can be configured to move the secondsliding portion to change the size of at least one opening of the one ormore coils.

In some embodiments, a pliable feedback unit can be disposed in aportion of the flexible filament body. Alternatively, a pliable feedbackunit can be coupled to a terminal end of the flexible filament body. Ineither instance, the pliable feedback unit can be configured to producean audible sound and/or tactile feedback when it moves from a bentconfiguration to a straight configuration. A feedback unit in someembodiments can have a known length extending from a terminal end of theflexible filament body, which can provide information about a locationof the flexible filament body in view of the known length of thefeedback unit. A feedback unit in some embodiments can be rigid and canbe coupled to the flexible filament body by way of a connectingfilament. The rigid feedback unit can be configured to engage bonesurrounding a tunnel to prevent the suture filament from passing throughthe tunnel.

In another exemplary embodiment, a surgical implant includes a filamentbody, a suture filament extending through the filament body at two ormore separate locations on the filament body to form one or more coils,and a tensioning tail. The filament body has an unstressedconfiguration, in which a first length of the filament body extendsbetween opposed terminal ends of the filament body. A portion of eachcoil is disposed on a top side of the body and a portion of each coil isdisposed on a bottom side of the body, with each coil defining anopening. The suture filament includes a slidable portion formed from thesuture filament. Movement of the slidable portion towards and away fromthe filament body causes a size of at least one opening of the one ormore coils to change. The tensioning tail extends from the slidableportion and is configured to move the slidable portion to change thesize of the at least one opening of the one or more coils. Further, thefilament body and the suture filament are configured such that thefilament body is reconfigurable from the unstressed configuration to ananchoring configuration. More particularly, applying tension to the oneor more coils in a direction away from the filament body causes thereconfiguration. In the anchoring configuration, the filament body has asecond length that extends between opposed terminal ends of thereconfigured filament body. Both the first and second lengths aremeasured along a longitudinal axis of the filament body, and the firstlength is greater than the second length. In other words, the filamentbody is longer in the unstressed configuration than it is in theanchoring configuration when both lengths are measured along alongitudinal axis.

In some embodiments, the tensioning tail can be formed from the suturefilament. In such embodiments, the slidable portion can include aslidable knot that is slidably adjustable by applying tension to thetensioning tail. Alternatively, in other such embodiments, the suturefilament can include a hollow portion, and the slidable portion caninclude a portion of the suture filament being disposed within thehollow portion. In such embodiments, the portion of the suture filamentdisposed within the hollow portion can be adjusted by applying tensionto the tensioning tail. Further, the suture filament can also include asecond hollow portion and a second slidable portion, with the secondslidable portion including a portion of the suture filament disposedwithin the second hollow portion. In such embodiments, the portion ofthe suture filament disposed within the second hollow portion can beadjusted by applying tension to a second tensioning tail formed from thesuture filament. The second tensioning tail can extend from the secondsliding portion and can be configured to move the second sliding portionto change the size of the opening of the one or more coils.

In some embodiments, a pliable feedback unit can be disposed in aportion of the filament body. Alternatively, a pliable feedback unit canbe coupled to a terminal end of the filament body. In either instance,the pliable feedback unit can be configured to produce an audible soundand/or tactile feedback when it moves from a bent configuration to astraight configuration. A feedback unit in some embodiments can have aknown length extending from a terminal end of the filament body, whichcan provide information about a location of the filament body in view ofthe known length of the feedback unit. A feedback unit in someembodiments can be rigid and can be coupled to the flexible filamentbody by way of a connecting filament. The rigid feedback unit can beconfigured to engage bone surrounding a tunnel to prevent the suturefilament from passing through the tunnel.

One exemplary embodiment of a surgical method includes loading a graftonto one or more coils of a suture filament that is coupled to aflexible filament body having a shuttle filament extending from it. Theshuttle filament is pulled through a bone tunnel, and thus the flexiblefilament body, the suture filament, and the graft are also pulled atleast partially through the bone tunnel. The shuttle filament is pulleduntil the flexible filament body is pulled out of the tunnel and atleast a portion of the suture filament and the graft remain in thetunnel. The flexible filament body is collapsed to draw terminal ends ofthe body that define a length of the body closer together, therebyplacing the flexible filament body in an anchored configuration in whichthe flexible filament body is disposed on one side of the bone tunneland the graft is disposed on an opposite side of the bone tunnel.

In some embodiments, collapsing the flexible filament body can includeapplying tension to the one or more coils in a direction away from theflexible filament body, which can cause the flexible filament body tocollapse. The suture filament can include a slidable portion formed fromthe suture filament, and a tensioning tail can extend from the slidableportion. In such embodiments, the method can include applying tension tothe tensioning tail to adjust a circumference of one or more coils ofthe suture filament. When the flexible filament body is pulled out ofthe tunnel, an audible sound and/or tactile feedback can be generated bya feedback unit associated with the flexible filament body to notify auser that the flexible filament body has passed through the tunnel. Insome embodiments, the feedback unit can be disposed in a portion of theflexible filament body, while in some other embodiments, the feedbackunit can be coupled to a terminal end of the flexible filament body.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIGS. 1A-1D are sequential, schematic, side, cross-sectional views of aprior art method for forming a bone tunnel in a bone for use inconjunction with an ACL repair;

FIG. 2 is a side view of one exemplary embodiment of a surgical implant;

FIGS. 3A-3C are sequential, schematic, side, cross-sectional views ofone exemplary method for using the surgical implant of FIG. 2 inconjunction with an ACL repair;

FIG. 4 is a side view of another exemplary embodiment of a surgicalimplant;

FIGS. 5A and 5B are sequential, schematic, side, cross-sectional viewsof one exemplary method for using the surgical implant of FIG. 4 inconjunction with an ACL repair;

FIGS. 6A-6D are sequential, schematic, side views of one exemplaryembodiment for forming a snare in a suture filament of the surgicalimplant of FIG. 4;

FIG. 7A is a schematic side view of another exemplary embodiment of asuture filament for use as part of a surgical implant;

FIG. 7B is a detail view of a coaxial region of the suture filament ofFIG. 7A identified by arrow B₁;

FIG. 8A is a side view of one exemplary embodiment of a filament bodyfor use as part of an exemplary embodiment of a surgical implant;

FIG. 8B is a side view of one exemplary embodiment of a suture filamentfor use as part of an exemplary embodiment of a surgical implant;

FIG. 8C is a side view of still another exemplary embodiment of asurgical implant, the implant including the suture filament of FIG. 8Bpassed through the filament body of FIG. 8A, and the implant being in aninitial, unactuated configuration;

FIG. 8D is a side view of the surgical implant of FIG. 8C, the implantbeing in an actuated configuration;

FIG. 9A is a side view of the surgical implant of FIG. 8C in theinitial, unactuated configuration and having a graft associatedtherewith;

FIG. 9B is a side view of the surgical implant of FIG. 9A associatedwith bone and in the actuated configuration;

FIG. 10A is a side view of yet another exemplary embodiment of asurgical implant;

FIG. 10B is a detailed, side, cross-sectional view of a portion of thesurgical implant of FIG. 10A identified by arrow B₂;

FIG. 11 is a side view of another exemplary embodiment of a surgicalimplant, the implant being similar to that of FIG. 10A except theimplant of FIG. 11 includes four coils instead of two coils as providedfor in the implant of FIG. 10A;

FIGS. 12A-12C are sequential, schematic, side, cross-sectional views ofone exemplary method for using the surgical implant of FIG. 10A inconjunction with an ACL repair, the surgical implant differing from thatof FIG. 10A in that it includes a filament tail;

FIG. 13 is a perspective view of one exemplary embodiment of a surgicalimplant having one exemplary embodiment of a pliable feedback unitdisposed approximately in a central portion of the implant;

FIGS. 14A-14D are sequential, schematic, side, cross-sectional views ofone exemplary embodiment for using the surgical implant of FIG. 13 inconjunction with an ACL repair;

FIG. 15A is a side view of one exemplary embodiment of a surgicalimplant having one exemplary embodiment of a feedback unit disposedapproximately at an end of the implant;

FIG. 15B is a side view of another exemplary embodiment of a surgicalimplant having another exemplary embodiment of a feedback unit disposedapproximately at an end of the implant;

FIG. 15C is a side view of still another exemplary embodiment of asurgical implant having still another exemplary embodiment of a feedbackunit disposed approximately at an end of the implant;

FIG. 15D is a top view of another exemplary embodiment of a feedbackunit configured to be disposed approximately at an end of a surgicalimplant;

FIG. 15E is a top view of yet another exemplary embodiment of a feedbackunit configured to be disposed approximately at an end of a surgicalimplant;

FIGS. 16A-16E are sequential, schematic, side, cross-sectional views ofone exemplary embodiment for using the surgical implant of FIG. 15A inconjunction with an ACL repair;

FIG. 17 is a side view of another exemplary embodiment of a surgicalimplant having another exemplary embodiment of a feedback unit disposedapproximately at an end of the implant;

FIGS. 18A-18E are sequential, schematic, side, cross-sectional views ofone exemplary embodiment for using the surgical implant of FIG. 17 inconjunction with an ACL repair;

FIG. 19A is a side view of one exemplary embodiment of a surgicalimplant having an exemplary embodiment of a feedback unit extendingdistally beyond a distal end of the implant;

FIG. 19B is a side view of the implant of FIG. 19A, the implant having asuture filament passing through a filament body;

FIGS. 20A-20E are sequential, schematic, side, cross-sectional views ofone exemplary embodiment for using the surgical implant of FIG. 19B inconjunction with an ACL repair; and

FIGS. 21A-21C are sequential, schematic, side, cross-sectional views ofa method for forming a bone tunnel in a bone for use in conjunction withan ACL repair in view of the various surgical implants provided forherein or derivable from the present disclosures.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention. Sizes and shapes of the devices, and thecomponents thereof, can depend at least on the anatomy of the subject inwhich the devices will be used, the size and shape of components withwhich the devices will be used, and the methods and procedures in whichthe devices will be used.

In the present disclosure, like-numbered components of the embodimentsgenerally have similar features and/or purposes. The figures providedherein are not necessarily to scale, although a person skilled in theart will recognize instances where they are to scale and/or what atypical size is when the drawings are not to scale. Further, to theextent arrows are used to describe a direction a component can betensioned or pulled, these arrows are illustrative and in no way limitthe direction the respective component can be tensioned or pulled. Aperson skilled in the art will recognize other ways and directions forcreating the desired tension or movement. Likewise, while in someembodiments movement of one component is described with respect toanother, a person skilled in the art will recognize that other movementsare possible. To the extent features or steps are described herein asbeing a “first feature” or “first step,” or a “second feature” or“second step,” such numerical ordering is generally arbitrary, and thussuch numbering can be interchangeable. Additionally, a number of termsmay be used throughout the disclosure interchangeably but will beunderstood by a person skilled in the art. By way of non-limitingexample, the terms “suture” and “filament” may be used interchangeably,and in some instances, simultaneously.

The present disclosure generally relates to a surgical implant for usein surgical procedures such as soft tissue (e.g., ACL) repairs. Moreparticularly, the devices provided for herein use a flexible filamentbody in conjunction with one or more filaments associated with the body,the one or more filaments being configured to hold a graft(s) to beimplanted at a surgical site. For example, the one or more filaments canbe formed into one or more coils that can receive and hold a graft(s).In some embodiments, the coil(s) can be adjustable such that as a sizeof an opening(s) defined by a coil(s) is changed, the location of thegraft(s) associated with the coil(s) with respect to the filament bodycan also change. The flexible filament body can be configured to beactuated between unstressed configurations in which terminal ends of thebody are generally opposed to each other approximately along alongitudinal axis of the body, and an anchoring configuration in whichthe body becomes more compact while being able to be positionedproximate to a bone tunnel to secure a location of the graft associatedwith the flexible filament body within the bone tunnel. In someembodiments, a feedback unit can be incorporated with, coupled to, orotherwise associated with the filament body to help notify a surgeonwhere the filament body is with respect to a bone tunnel through whichthe body is passing.

One exemplary embodiment of an implant 20 is provided in FIG. 2. Asshown, the implant 20 includes a flexible filament body 40 and a suturefilament 60, sometimes referred to as a suture repair construct,associated with the body 40. The flexible filament body 40 extendsbetween terminal ends 40 a, 40 b to define a length k_(U) of thefilament, and thus the body 40. The body 40 can include a plurality ofopenings 46 that extend from a top side 42 to a bottom side 44 of thebody 40. The openings 46 can be pre-formed by virtue of the constructionand material of the filament (e.g., it can be a braided filament), orone or more of the openings 46 can be formed to receive suture filament,such as by creating openings where one did not previously exist or byexpanding an existing opening to pass a repair construct through theformed opening.

As shown, the body 40 can have a leading tail 50 associated with it. Inthe illustrated embodiment, the leading tail 50 extends from theterminal end 40 b and is part of the same material that is used to formthe flexible filament body 40. In other embodiments, the leading tail 50can extend from a different portion of the body 40 and/or it can be itsown separate filament that is coupled to or otherwise associated withthe body 40. The leading tail 50 can be used to help maneuver theflexible filament body 40 during a surgical procedure, such as passingit through a bone tunnel, as described in greater detail below.

The flexible filament body 40 is reconfigurable between an unactuated orunstressed configuration, shown in FIGS. 2 and 3A, and an actuated oranchoring configuration, shown in FIGS. 3B and 3C. In the unactuated orunstressed configuration, the terminal ends 40 a, 40 b approximatelydefine the length l_(U), although because the body 40 is flexible, thebody 40 may not always be in an approximate straight line. This isillustrated by FIG. 3A, in which the flexible filament body 40 is stillin the unactuated or unstressed configuration even though terminal end40 a is not co-linear with terminal end 40 b along a longitudinal axis Lof the body 40. Nevertheless, the length l_(U) in the unactuated orunstressed configuration is the length of the filament when the body 40is approximately in a straight line, as shown in FIG. 2.

In the actuated or anchoring configuration, the terminal ends 40 a, 40 bcollapse towards a center 48 of the body 40 such that a resulting lengthl_(A) of the body 40 is smaller than the length l_(U). Notably, whilethe length l_(U) is defined by the length when the body is approximatelyin a straight line, such a requirement is not applicable to the lengthl_(A) because once the body is in the actuated or anchoringconfiguration, it is not easily manipulated back into a substantiallycollinear configuration along a longitudinal axis at least because itcannot be easily unwound. Further, in the illustrated embodiment ofFIGS. 3B and 3C, the openings 46 of the body 40 through which the suturefilament 60 is disposed also collapse towards the center 48, asdemonstrated by the movement of openings 46 a and 46 b between FIGS. 3Aand 3B. Thus, the terminal ends 40 a, 40 b, and as shown the openings 46(e.g., 46 a, 46 b), are typically closer together in the anchoringconfiguration than they are in the unstressed configuration. However,again, in view of the flexible nature of the body 40, certainly the body40 can be manipulated in other ways to place terminal ends 40 a, 40 band/or openings 46 closer together even though the body 40 is in theunstressed configuration. Such movement does not depart from the spiritof the present disclosure. A person skilled in the art will recognizethe differences between the unstressed and the anchoring configurations,and in particular how the lengths of the body 40 are defined in bothconfigurations, and other ways the different configurations can bedistinguished (e.g., density, distances between selection locations,etc.), in view of the present disclosures.

Another non-limiting example of a typically distinguishingcharacteristic between the two configurations is that generally adensity of the body 40 is greater in the anchoring configuration than inthe unstressed configuration. Even as the density of the body 40increases, and a length defined by the terminal ends 40 a, 40 bdecreases in the anchoring configuration as compared to the unstressedconfiguration, the length l_(A) is still greater than a diameter d₁ ofan adjacent bone tunnel 1102 so that the body 40 does not pass throughthe tunnel 1102, as described in greater detail below. As also describedin greater detail below, actuating the flexible filament body 40 fromthe unstressed configuration to the anchoring configuration can beachieved by applying tension in a direction away from the flexiblefilament body 40, for instance by pulling approximately in a direction Con coils 62 a, 62 b of the suture filament 60, as shown in FIG. 3B.Typically pulling the leading tail 50 does not actuate the filament body40, although in some other embodiments, a second tail can be associatedwith the filament body 40 with one tail being configured for the samepurposes as the leading tail 50 as described herein, and the other tailbeing configured to actuate the flexible filament body 40. A personskilled in the art, in view of the present disclosures, would understandhow to associate a second tail with the body 40 to allow the tail toinitiate actuation of the body 40.

The suture filament 60 can be associated with the flexible filament body40 in a number of different ways to allow the suture filament 60 toengage a graft 90 to be implanted and establish a location of the graft90 with respect to the flexible filament body 40. As shown in FIGS.2-3C, the suture filament 60 is passed through the openings 46 multipletimes to form two coils or loops 62 a, 62 b for receiving a graft withinopenings 64 a, 64 b defined by the coils or loops 62 a, 62 b and thebottom side 44 of the flexible filament body 40. While a majority of thecoils 62 a, 62 b are disposed below the flexible filament body 40, withan area below the flexible filament body 40 illustrated as area Z inFIG. 2, a portion is disposed above the flexible filament body 40, withan area above the flexible filament body 40 illustrated as area Y inFIG. 2. The suture filament 60 can also include a slidable portion 70disposed above the flexible filament body 60. As shown, the slidableportion 70 is a sliding knot 72. A number of different sliding knots canbe used, including but not limited to a Lark's Head knot, a BuntlineHitch knot, a Tennessee Slider knot, a Duncan Loop knot, and a Hangman'sNoose knot. The knot 72 can also be self-locking.

One or more filament tails 80, 82 can extend from the slidable portion.In the illustrated embodiment, two tails or limbs 80, 82 formed byopposed terminal ends of the suture filament 60 extend from the knot 72,with one tail 80 serving as a closure or tensioning tail operable toadjust a size of the openings 64 a, 64 b of the coils 62 a, 62 b, andthe other tail 82 serving as a stationary tail, on which one or morehalf-hitches can be formed at the conclusion of procedure to maintain alocation of the knot 72 with respect to the flexible filament body 40.In other embodiments, both tails 80, 82 can be operable to adjust a sizeof one or more openings of the coils. The size of the openings 64 a, 64b can be adjusted, for example, by applying tension away from the knot72, as shown approximately in a direction K in FIG. 3C, thereby slidingthe tensioning tail 80 in that direction and causing the size of theopenings 64 a, 64 b to decrease.

The implant 20 can be used in conjunction with a bone tunnel 1100, e.g.,a femoral tunnel. Some exemplary descriptions and illustrations ofmethods for forming bone tunnels are provided later herein with respectto FIGS. 21A-21C, and are thus not discussed in this section. FIGS.3A-3C provide for method steps involved with implanting and, afterpassing a flexible filament body 40 of the implant 20 through the bonetunnel 1100, actuating the body 40 into the anchoring configuration. Asshown in FIG. 3A, the bone tunnel 1100 includes the implant-receivingtunnel 1102 and a graft tunnel 1106, with the graft tunnel 1106 having adiameter d₂ that is greater than the diameter d₁ of the implant-passingtunnel 1102. As also shown in FIG. 3A, the implant 20 has a graft 90disposed through both openings 64 a, 64 b, thus providing greaterstrength than if the graft 90 was passed through just one of the twoopenings. The graft 90 can be associated with the coils 62 a, 62 b atany time. After the filament body 40 is pulled through the tunnel 1100by way of the leading tail 50, it is still in an unstressedconfiguration, with at least a portion of the coils 62 a, 62 b extendingtherefrom still disposed within at least a portion of the tunnel 1100.

Tension can be applied to the filament body 40 by applying tension tothe graft 90 approximately in the direction C away from the body asshown in FIG. 3B. This causes the flexible filament body 40 to constrictand advance from the unstressed configuration to the actuated oranchoring configuration. As discussed above, the length l_(A) of thefilament body in the anchoring configuration, which as shown can also beconsidered a diameter of the resulting body 40, is greater than thediameter d₁ of the implant-passing tunnel 1102 that is adjacent to thebody 40. Tension can then be applied to the closure tail 80 to decreasea size of the openings 64 a, 64 b, which in turn pulls the graft 90towards and into the tunnel 1100, as shown in FIG. 3C. One or morehalf-hitches can be formed proximate to the sliding knot 72 to lock thesliding knot 72 in place, and thus maintain a location of the knot 72,the coils 62 a, 62 b, and the graft 90 with respect to the body 40.

Notably, although in the illustrated embodiment the flexible filamentbody 40 is actuated to move into the anchoring configuration by applyingtension to the graft 90, and thus the coils 62 a, 62 b, a person skilledin the art, in view of the present disclosures, will recognize a varietyof other components and methods that can be used to initiate thereconfiguration of the body 40 from the unstressed configuration to theanchoring configuration. By way of non-limiting example, in someembodiments, a separate actuation limb or tail can extend from thefilament body 40, and can be used to initiate the collapse of the body40. Such a tail can extend away from the body 40 from a similar locationas the leading tail 50, can extend away from the body 40 from theopposite terminal end 40 a, or from an intermediate portion of the body40. Likewise, although in the illustrated embodiment two coils 62 a, 62b are used to support a single graft 90, in other embodiments, each coil62 a, 62 b can have a graft associated therewith, and the two tails 80and 82 can be configured to individually control respective coils 62 a,62 b such that the grafts can be selectively moved by applying tensionto either of the two tails 80, 82. Exemplary disclosures related toforming coils from a suture filament, and using the same during asurgical procedure, are provided for at least in U.S. Patent ApplicationPublication No. 20140257346 of Sengun, et al. and U.S. PatentApplication Publication No. 20150157449 of Gustafson, et al., thecontent of each which is incorporated by reference herein in theirrespective entireties. A person skilled in the art would be able toincorporate those teachings that are incorporated by reference into theimplants provided for herein, including using such teachings inconjunction with the flexible filament bodies, without much difficultyin view of the present disclosures.

FIG. 4 provides an alternative embodiment of an implant 120 having aflexible filament body 140 and a suture filament or suture construct 160associated with the body 140. The filament body 140 is similar to thefilament body 140 of FIGS. 2-3C, and includes terminal ends 140 a, 140 bthat define a length l_(U)′ as shown when the body 140 is in anunactuated or unstressed configuration and the terminal ends 140 a, 140b are substantially co-linear along a longitudinal axis L′ of the body140 as shown. Multiple openings 146 exist in the body 140 for having therepair construct 160 passed therethrough, and a leading tail 150 extendsfrom the terminal end 140 b to help maneuver the flexible filament body140 during a surgical procedure. The body 140 is reconfigurable betweenthe unactuated or unstressed configuration illustrated in FIG. 4 and anactuated or anchoring configuration illustrated in FIGS. 5A and 5B, inwhich a length l_(A)′ of the body 140 is defined as approximately as adiameter of the resulting collapsed body 140.

The suture filament or repair construct 160 can be associated with theflexible filament body 140 in a number of different ways to allow thesuture filament to engage a graft 190 to be implanted and establish alocation of the graft 190 with respect to the filament body 140. Asshown in FIGS. 4-5B, the suture filament 160 is passed through theopenings 146 multiple times to form two coils or loops 162 a, 162 b, atleast one of which can be used for receiving the graft 190 within theopening 164 a, 164 b defined by the respective coil or loop 162 a, 162 band a bottom side 144 of the flexible filament body 140. The coils 162a, 162 b are different than those of FIGS. 2-3C in that each coilincludes two limbs of filament passing through each opening 146 of thefilament body rather 140 rather than just one limb. While a majority ofthe coils 162 a, 162 b are disposed below the flexible filament body140, with an area below the flexible filament body illustrated as areaZ′ in FIG. 4, a portion is disposed above the flexible filament body140, with an area above the flexible filament body illustrated as areaY′ in FIG. 4.

The suture filament 160 can also include a slidable portion 170 disposedabove the flexible filament body 140. As shown, the slidable portion 170is a sliding knot 172. A number of different sliding knots can be used,including but not limited to a Lark's Head knot, a Buntline Hitch knot,a Tennessee Slider knot, a Duncan Loop knot, and a Hangman's Noose knot.The knot 172 can also be self-locking. The construct 160 can alsoinclude one or more closure tails or limbs 180, 182 that extend from theslidable portion 170, and which can be operable to control a size of theopenings 164 a, 164 b in manners described herein or otherwise known tothose skilled in the art. In the illustrated embodiment, both tails 180,182 serve as closure tails, and thus tension applied to either canchange a size of at least one of the openings 164 a, 164 b. In otherembodiments, one of the tails 180, 182 may be a stationary tail.

FIGS. 5A and 5B both illustrate the flexible filament body 140 in theactuated or anchoring configuration with a graft 190 passing through theopenings 164 a. The implant 120 is used in conjunction with a bonetunnel 1100′, e.g., a femoral tunnel, having a configuration similar tothe one described above, and thus includes an implant-receiving tunnel1102′ having a diameter that is less than a graft tunnel 1106′.

Similar to the flexible filament body 40, the flexible filament body 140can be actuated by applying tension in a direction away from the body,such as by applying tension approximately in a direction C′ to the graft190 and/or the coil 162 a, as shown in FIG. 5A. As shown in FIG. 4, theother coil 162 b is proximate to the body 140 as the body 140 isactuated, and the coil 162 b actually becomes part of the mass thatdefines the body 140 in the anchoring configuration, as shown in FIGS.5A and 5B. Tension can then be applied to the closure tails 180, 182,for instance by applying it approximately in a direction K′ as shown inFIG. 5B, to decrease a size of the opening 164 a, and in turn pull thegraft 190 towards and into the tunnel 1100′ as shown in FIG. 5B. As alsoshown in FIG. 5B, one or more-half hitches 184 can be formed on at leastone of the tails 180, 182 to lock the sliding portion 170 in place, andthus maintain a location of the sliding portion 170, the coil 162 a, andthe graft 190 with respect to the body 140.

FIGS. 6A-6D illustrate one exemplary method for forming the repairconstruct 160 of FIGS. 4-5B. In this embodiment, the portion of filament160 that forms the coils 162 a, 162 b is formed from a bifurcated suturefilament having a tubular portion 165 with a core removed to form acannulated portion 166 and first and second terminal limbs 167, 168. Asshown in FIG. 6B, the terminal limbs 167, 168 can be curled back towardthe tubular portion 165 to form a loop having an opening that definesthe portions that will become the coils once associated with thefilament body. As shown in FIG. 6C, a bore 169 can be formed on a sideof the tubular portion 165 and the terminal limbs 167, 168 can be placedinto the cannulated tubular portion 166 through the bore 169. Ends ofthe terminal limbs 167, 168 can be fed through the cannulated portion166, and as shown in FIG. 6D, the terminal limbs 167, 168 can be pulleddistally (approximately in a direction M in FIG. 6D) through the tubularportion 165 such that the tubular portion 165 is fed through itself.Accordingly, the filament that forms the coils can be collapsed bytensioning the limbs 167, 168 in approximately the direction M.

Although in the embodiment illustrated in FIGS. 6A-6D the portions offilament 160 that will become the coils are defined by a portion of afilament sliding inside of itself, a person skilled in the art willrecognize that in alternative embodiments the filament 160 can be formedinto a sliding knot to define the portion of filament that becomes thecoils. A number of different sliding knots can be used, including butnot limited to a Lark's Head knot, a Buntline Hitch knot, a TennesseeSlider knot, a Duncan Loop knot, and a Hangman's Noose knot, and theknot can be self-locking. To the extent the sliding knot used to formthe portion of filament that becomes the coils impacts the operation ofthe coils, for instance whether a limb is pulled through a knot tochange the position of the knot or a knot is slid along a limb to changethe position of the knot, a person skilled in the art would be able toadapt these types of knots for use with the teachings of the presentdisclosure without departing from the spirit of the present disclosure.

FIGS. 7A and 7B illustrate an alternative embodiment of a repairconstruct 160′ that can be used in conjunction with the implant 120 ofFIGS. 4-5B. In this embodiment, a slidable portion is defined by a snare172′, which itself is defined by a sliding knot 173′. The portion thatextends from an opposite side of the sliding knot 173′, i.e., away fromthe snare 172′, are limbs 174′, 175′ that form the portion of theconstruct 160′ that will become the coils, and then, optionally, one ofthe two limbs is passed through itself in a coaxial region 176′ so thata terminal end of the construct 160 t′ includes only a single filament177′. More particularly, the repair construct 160′ is generally formedfrom a single elongate filament that is folded to form a first limb 174′and a second limb 175′. The first limb 174′ can generally be longer thanthe second limb 175′, and the two limbs can be used to form both thesnare 172′ and the coaxial region 176′. The snare 172′, which isdisposed on a first end 160 a′ of the construct 160′, can be configuredto receive an opposite end 160 b′ of the construct 160′ and is operableto collapse around a portion of the construct disposed in an opening171′ thereof. The portion that then extends through and out of the snare172′ defines the tail(s) used to adjust a size of openings of coilsdefined by the intermediate portions of filament 160′. The coaxialregion 176′ is generally configured to allow the shorter second limb175′ to be disposed within a volume of the first limb 174′, therebyeliminating any additional component for suture management, such as asleeve. The first limb 174′ can then extend beyond the coaxial region176′ to form a tail 177′ of the construct 160′.

The collapsible snare 172′ can be formed using any number of techniquesknown to those skilled in the art. In the illustrated embodiment thefirst and second limbs 174′, 175′ are formed to include a sliding knot173′. The sliding knot 173′ is configured such that as it moves towardthe coaxial region 176′, a size of the opening 171′ defined by the snare172′ increases, and as the knot 173′ moves away from the coaxial region176′, the size of the opening 171′ decreases. Some exemplary knot typesinclude a Lark's Head knot, an Overhand Knot, and a Blood knot, and theknot can be a self-locking knot. A person skilled in the art willunderstand that in other configurations, a size of the opening 171′defined by the snare 172′ may be adjusted in different manners,depending on the type of knot, desired use, etc. Some exemplary snareand formations thereof are described in U.S. Patent ApplicationPublication No. 2012/0130424 of Sengun et al. and U.S. Pat. No.9,060,763 to Sengun, the content of which is incorporated by referencein their entireties.

The coaxial region 176′ in the illustrated embodiment is formed bypassing terminal end 175 t′ of the second limb 175′ into a volume of thefirst limb 174′. As shown in FIG. 7B, at least a portion of the firstlimb 174′ can be cannulated, and an opening 179′ on a side of the firstlimb 174′ allows the second limb 175′ to be disposed in the first limb174′. The opening 179′ can be created manually by forming a hole in theside of the first limb 174′ and removing a core of the first limb 174′so that there is space to receive the second limb 175′. Alternatively,the filament of the first limb 174′ can be a braided suture with a coreremoved from at least the portion of the first limb 174′ that is part ofthe coaxial region 176′, thereby allowing the first limb 174′ to receivethe second limb 175′. In other embodiments a core of a filament, braidedor otherwise, is not removed and the second limb 175′ is still disposedin first limb 174′ using techniques known to those skilled in the art. Ajunction B₁ at which the second limb 175′ engages the first limb 174′can be a self-maintaining junction. As a result, pulling on the tail177′ of the surgical construct 160′ does not cause the second limb 175′to pull out of the first limb 174′. Rather, pulling on the tail 177′ canactually force the first limb 174′ to collapse around the second limb175′, thereby providing sufficient friction between the two limbs 174′and 175′ to hold them together. The two limbs 174′ and 175′, however,can be separated manually at the junction B₁ by applying a sufficientamount of force. Although in the illustrated embodiment the junction B₁is formed by inserting the terminal end 175 t′ of the second limb 175′into a portion of the first limb 174′, a person skilled in the art willunderstand other ways by which the junction can be formed withoutdeparting from the spirit of the present disclosure.

The tail 177′ of the construct 160′ is formed by the remaining portionof the first limb 174′ that extends beyond the coaxial region 176′. Thetail 177′ can be used, for example, to help lead insertion of theconstruct 160′ into a flexible filament body, e.g., the bodies 40 and140, among other things. Additionally, although in the illustratedembodiment a single filament is used to form the first and second limbs174′ and 175′, a separate filament can be used for each of the first andsecond limbs 174′ and 175′ without departing from the spirit of thedisclosures provided herein. Still further, a person skilled in the artwill recognize that the methods of forming repair constructs describedwith respect to FIGS. 6A-7B are just some exemplary embodiments forsuture filament or repair construct formations that can be used inconjunction with the disclosures to implants provided for herein. Manyother methods can be used to form the repair constructs of the presentdisclosure without departing from the spirit of the present disclosure.By way of non-limiting example, in some embodiments the first and secondlimbs 174′ and 175′ can be maintained as separate limbs and used in amanner as illustrated with respect to the implant 120 of FIG. 4.

Another exemplary embodiment of an implant 220 is provided for in FIGS.8A-9B, with FIGS. 8A and 8B providing a flexible filament body 240 and asuture filament or repair construct 260, respectively, FIGS. 8C and 8Dillustrating the body 240 and construct 260 coupled together orotherwise associated with each other in the unactuated or unstressedconfiguration (FIG. 8C) and the actuated or anchoring configuration(FIG. 8D) to form the implant 220, and FIGS. 9A and 9B illustrating theimplant 220 associated with a graft 290 (FIGS. 9A and 9B) and implantedat a surgical site that includes a bone tunnel 1100″, e.g., a femoraltunnel. As shown, the flexible filament body 240 of FIG. 8A is similarto the filament bodies of FIGS. 2-3C and 4-5B, and includes terminalends 240 a, 240 b that define a length l_(U)″ as shown when the body 240is in an unactuated or unstressed configuration and the terminal ends240 a, 240 b are substantially co-linear along a longitudinal axis L″ ofthe body 240. Multiple openings 246 (visible better in FIG. 8C based onlocations through which the repair construct 260 passes) exist in thebody 240 for having the repair construct 260 passed therethrough, and aleading tail 250 extends from the terminal end 240 b to help maneuverthe flexible filament body 240 during a surgical procedure. The body 240is reconfigurable between the unactuated or unstressed configurationillustrated in FIG. 8C and an actuated or anchoring configurationillustrated in FIG. 8D, in which a length l_(A)″ of the body 240 isdefined as approximately as a diameter of the resulting collapsed body240.

The suture filament or repair construct 260 includes a snare 272, asliding knot 273 that defines a size of the snare 272, and two tails274, 275 extending from the snare 272. The portion of the filament 260that is the snare 272 is the portion that will become the coils 262 a,262 b (FIG. 8C) when the body 240 and suture filament 260 are coupledtogether. The sliding knot 273 can be configured such that as it movesapproximately in a direction V as shown in FIG. 8B, a size of theopening 271 defined by the snare 272 decreases, and as the knot 273moves approximately in a direction W as shown FIG. 8B, the size of theopening 271 increases. Some exemplary knot types include a Lark's Headknot, a Buntline Hitch knot, a Tennessee Slider knot, a Duncan Loopknot, and a Hangman's Noose knot, and the knot can be a self-lockingknot. A person skilled in the art will understand that in otherconfigurations, a size of the opening 271 defined by the snare 272 maybe adjusted in different manners, depending on the type of knot, desireduse, etc. Some exemplary snare and formations thereof are described inapplications and patents previously incorporated by reference above.

As shown, one or more filament tails 274, 275 extend from the slidingknot 273. In the illustrated embodiment, two tails 274, 275 formed byopposed terminal ends of the suture filament 260 extend from the knot273. One tail 274 serves as a closure tail operable to adjust a size ofthe opening 271 of the snare 272, and thus a size of openings 264 a, 264b of the coils 262 a, 262 b (FIG. 8C) once the suture filament 260 isassociated with the flexible filament body 240 as provided for withrespect to FIGS. 8C and 8D, and the other tail 275 serves as astationary tail, on which one or more half-hitches can be formed at theconclusion of procedure to maintain a location of the knot 273 withrespect to the flexible filament body 240. At least in embodiments inwhich the sliding knot 273 is a locking knot, one or more half-hitchesmay not be used. As described above, in other embodiments, both tails274, 275 can be operable to adjust a size of the snare 272, and thus asize of the openings 264 a, 264 b defined by the coils 262 a, 262 b.

The repair construct 260 can be associated with the flexible filamentbody in a number of different ways to allow the construct 260 to engagea graft to be implanted and establish a location of the graft withrespect the flexible filament body 240. As shown in FIGS. 8C and 9A, theconstruct 260 is passed through the openings 246 multiple times to formtwo coils or loops 262 a, 262 b for receiving a graft 290 (FIGS. 9A and9B) within openings 262 a, 264 b defined by the coils or loops 262 a,262 b and a bottom side 244 of the flexible filament body 240. Theimplant 20 had a single limb of filament define each coil 62 a, 62 b forreceiving a graft, while the implant 120 had two limbs of filamentdefine each coil 162 a, 162 b for receiving a graft. The implant 220includes one coil having each configuration. As shown in FIG. 8C, thefirst coil 262 a includes two limbs, each defining the opening 264 a forreceiving a graft, while the second coil 262 b includes a single limbthat defines the opening 264 b for receiving a graft. In use asillustrated in FIGS. 9A and 9B, the three limbs and two coils 262 a, 262b are used together to provide additional strength for holding a singlegraft 290. A person skilled in the art, in view of the presentdisclosures, however, will recognize a variety of different ways coilscan be formed and used separately and together to receiving one or moregrafts. Further, in the illustrated embodiment, unlike previouslyillustrated embodiments, the slidable portion or knot 273 is notdisposed centrally with respect to flexible filament body 240. Theslidable portion of the repair constructs of any of the implantsprovided for herein can generally disposed anywhere along a length ofthe flexible filament body of the implants.

While a majority of the coils 262 a, 262 b are disposed below theflexible filament body 240, with an area below the flexible filamentbody 240 illustrated as area Z″ in FIGS. 8C and 9A, a portion isdisposed above the flexible filament body 240, with an area above theflexible filament body 240 illustrated as area Y″ in FIGS. 8C and 9A.The slidable portion of the construct 260 that is disposed above theflexible filament body 240 is the sliding knot 273 that defines thesnare 272. Similar to the earlier configurations, the filament body 240can be actuated to form the anchoring configuration illustrated in FIGS.8D and 9B by applying tension in a direction away from the body, such asby applying tension approximately in a direction C″ away from the body240 as shown in FIGS. 8C and 9A. Tension can then be applied to theclosure tail 274, for instance by applying it approximately in adirection K″ as shown in FIG. 9B, to decrease a size of the openings 264a, 264 b, which in turn pulls the graft 290 disposed within the openings264 a, 264 b towards the flexible filament body 240 and into the grafttunnel 1106″. Similar to earlier embodiments, the bone tunnel 1100″illustrated in FIG. 9B includes both the graft tunnel 1106″ and theimplant-passing tunnel 1102″, with a diameter d₂″ of the graft tunnel1106″ being larger than the diameter d₁″ of the implant-passing tunnel1102″. Formation of such tunnels 1102″ and 1106″ is provided for belowwith respect to FIGS. 21A-21C. One or more half-hitches can be formed onthe tail 275 proximate to the sliding knot 273 to lock the sliding knot273 in place, and thus maintain a location of the knot 273, the coils262 a, 262 b, and the graft 290 with respect to the body 240.

FIGS. 10A-12C illustrate two exemplary embodiments of an implant 320,320′ that includes a flexible filament body 340, 340′ and a suturefilament or repair construct 360, 360′ associated with the body 340,340′ in which a slidable portion 370, 370′ of the construct 360, 360′ isa coaxial region 372, 372′. In alternative embodiments, the coaxialregion can be a separate sleeve disposed in locations illustrated wherea hollow portion of the filament includes another portion of thefilament passing therethrough.

The implant 320 of FIG. 10A includes a flexible filament body 340 thatis similar to the flexible filament bodies 40, 140, 240 described aboveexcept it does not include a leading tail. Alternatively, the body 340can include a filament tail 350, as illustrated in FIGS. 12A-12C. Theflexible filament body 340 includes terminal ends 340 a, 340 b thatdefine a length l_(U)′″ (not shown) when the body 340 is in anunactuated or unstressed configuration and the terminal ends 340 a, 340b are substantially co-linear along a longitudinal axis (not shown) ofthe body 340. Such a configuration is not illustrated, but is easilyderivable based on other configurations and descriptions provided forherein and the knowledge of those skilled in the art. In embodiments inwhich a filament tail 350 is provided, the leading tail 350 can bedisposed approximately at a midpoint E with respect to the lengthl_(U)′″ of the filament body 340, as shown in FIG. 12A. Alternatively,it can be disposed at other locations, including but not limited to aterminal end 340 b as provided for in other embodiments herein. Similarto leading tails described above, in some embodiments the filament tail350 can be a part of the filament that forms the flexible filament body340, while in other embodiments the filament tail 350 can be a separatefilament that is coupled to the flexible filament body 340 using anytechniques known to those skilled in the art.

Multiple openings 346 exist in the body 340 for having the repairconstruct 360 passed therethrough, and similar to other embodiments, thebody 340 is reconfigurable between an unactuated or unstressedconfiguration illustrated in FIGS. 10A and 12A, and an actuated oranchoring configuration illustrated in FIGS. 12B and 12C. Notably, inthe illustrated unstressed configuration, the flexible filament body 340can be bent, as provided for in FIGS. 10A and 12A, but it is still notin a denser, balled up type configuration like it is in the anchoringconfiguration as provided for in FIGS. 12B and 12C and in otherembodiments of an implant herein. As described herein, however, thelength l_(U)′″ of the flexible filament body 340 in the unstressedconfiguration is still a length that can be formed while the body 340 isunactuated, i.e., by the terminal ends 340 a, 340 b being collinearalong a longitudinal axis of the body 340, while a length l_(A)′″ in anactuated or anchoring configuration is approximately the diameter of theballed up configuration, as illustrated in FIGS. 12B and 12C.

The coaxial region 372 that is the slidable portion 370 of the implant320 can be formed in a variety of ways to form such regions known bythose skilled in the art. In the illustrated embodiment, the filament360 includes a hollow portion through which another portion of thefilament passes. More specifically, as shown in FIG. 10B, a portion ofthe filament passed through a first opening 369 in the filament 360,through the hollow portion 366, and out of a second opening 363 in thefilament. The portion of filament 360 disposed in the hollow portion 366can change as a result of the slidable nature of the configuration,which in turn can adjust a size of openings of the coils or loops 362 a,362 b formed by the filament 360, which as illustrated in FIG. 10A anddescribed in greater detail below when describing how the filament 360is coupled to or otherwise associated with the flexible filament body340. The hollow portion 366 can be formed using any known techniques,including the filament 360 already being pre-formed to include a hollowportion or forming the hollow portion 366 by removing a portion of acore of the filament 360. The portion of the filament 360 that isdisposed within the hollow portion 366 can engage with the portions ofthe filament 360 surrounding the openings 369, 363 through which itpasses to act like a Chinese finger trap. Those skilled in the art willunderstand how such an interaction works, and thus a further explanationof a Chinese finger trap is unnecessary.

The repair construct 360 can be associated with the flexible filamentbody 340 in a number of different ways to allow the suture filament 360to engage a graft to be implanted and establish a location of the graftwith respect to the filament body 340. As shown in FIGS. 10A and 12A,the suture filament 360 is passed through the openings 346 multipletimes to form two coils or loops 362 a, 362 b for receiving a graft 390within openings 364 a, 364 b defined by the coils or loops 362 a, 362 band a bottom side 344 of the flexible filament body 340. In theillustrated embodiment, the coaxial region 372 is part of the suturefilament 360 that is passed through the flexible filament body 340,which can help keep a length of the implant 320 that goes through animplant-passing tunnel 1102′″ (FIG. 12A) at a minimum (e.g., a diameterof the tunnel 1102′″ being as small as 2 millimeters). Any portion ofthe suture filament 360 can be the portion that is passed through theflexible filament body 340.

As shown in FIGS. 10A and 12A, the coils or loops 362 a, 362 b areformed by portions of the suture filament 360 that extend away from theflexible filament body 340. More particularly, both a portion of thefilament 360 that forms the hollow portion 366 of the coaxial region 372through which another portion of the filament 360 passes, and theportion of the filament 360 that passes through the hollow portion 366form the coils or loops 362 a, 362 b. Similar to other embodiments,while a majority of the coils 362 a, 362 b are disposed below theflexible filament body 340, with an area below the body illustrated asarea Z′″ in FIG. 10A, a portion is disposed above the body, with an areaabove the body illustrated as area Y′″ in FIG. 10A.

More particularly, the coaxial regions 372 are disposed at either end ofan intermediate portion 382 of the suture filament 360 disposed betweenthe two coaxial regions 372. The first loop 362 a is formed by thesuture filament 360 extending away from the filament body and thecoaxial region 372 that is proximate to the terminal end 340 a of thefilament body 340 in FIG. 10A, and then passing through the othercoaxial region 372, i.e., the coaxial region 372 that is proximate tothe terminal end 340 b of the filament body 340 in FIG. 10A, with theportion that exits the other coaxial region 372 forming the closure limb380. Likewise, the second loop 362 b is formed by the suture filament360 extending away from the filament body 340 and the other coaxialregion 372, again the coaxial region 372 that is proximate to theterminal end 340 b of the filament body 340 in FIG. 10A, and thenpassing through the first coaxial region 372, i.e., the coaxial region372 that is proximate to the terminal end 340 a of the filament body 340in FIG. 10A, with the portion that exits the first coaxial region 372forming the closure limb 380. Operation of the closure limbs 380 can beeffective to adjust a size of all of the openings 364 a, 364 b of thecoils or loops 362 a, 362 b.

In alternative embodiments of an implant 320′, more than two loops orcoils can be formed. As shown in FIG. 11, four loops or coils 362 a′,362 b′, 362 c′, 362 d′ are provided, with the two additional coils orloops being formed by passing suture filament 360′ through openings 346′of a filament body 340′ multiple more times. The multiple additionalpasses in the illustrated embodiment do not include additional coaxialregions 372′, and instead involve the suture filament 360′ just passingthrough the flexible filament body 340′, although additional coaxialregions can be formed if desired. Similar to the earlier describedembodiment, operation of closure limbs 380′ can be effective to adjust asize of all of openings 364 a′, 364 b′, 364 c′, 364 d′ defined by thecoils or loops 362 a′, 362 b′, 362 c′, 362 d′.

FIGS. 12A-12C illustrate one exemplary method for passing the implant320 through a bone tunnel 1100′″, e.g., a femoral tunnel. The tunnel1100″ includes both an implant-passing tunnel 1102′″ and a graft tunnel1106′″, the formation of which is described below with respect to FIGS.21A-21C. Additionally, a graft 390 is passed through the openings 364 a,364 b formed by the coils 362 a, 362 b. The implant 320 can be passedthrough the tunnel 1100′″ by applying tension to the filament tail 350approximately in a direction Q to advance the implant 320 through thegraft tunnel 1106′″, and into and subsequently out of theimplant-passing tunnel 1102′″. As shown, the flexible filament body 340can also exit the implant-passing tunnel 1102′″, while at least aportion of the coils 362 a, 362 b remains disposed within both theimplant-passing and graft tunnels 1102′″, 1106′″. As described earlierwith respect to the leading tails 50, 150, 250, typically applyingtension to the filament tail 350 does not cause the flexible filamentbody 340 to actuate. The flexible filament body 340 can be actuated,however, by applying tension to the one or more coils 362 a, 362 b in adirection away from the flexible filament body, as shown approximatelyin a direction C′″ in FIG. 12B. The flexible filament body 340 thenfurther collapses upon itself into a balled up, denser configuration asshown. In some embodiments, at least a portion of the coaxial region 372can be drawn into the mass that forms the flexible filament body 340 inits anchoring configuration. As shown in FIG. 12C, tension can beapplied to the closure limbs 380, for instance approximately in adirection K′″, to decrease a size of the openings 364 a, 364 b of thecoils 362 a, 362 b, and thus draw the graft 390 into, or further into,the graft tunnel 1106′″.

Both the flexible filament body 40, 140, 240, 340, 340′ and the suturefilament or repair construct 60, 160, 260, 360, 360′ can be formed froma variety of materials in a variety of forms. The type of filaments andmaterials of the filaments for the body and the construct can be similaror different for the same implant. Typically, the materials that areused to form both the body and repair construct are what a personskilled in the art would consider to be soft materials, which helpsminimize unwanted trauma on the tissue with which the implant is used.In one exemplary embodiment, the flexible filament body is formed usinga surgical filament, such as a braided filament. The type, size, andstrength of the materials used to form the flexible filament body candepend, at least in part, on the materials and configuration of therepair construct, the type of bone or tissue with which it will be used,and the type of procedure with which it will be used. In one exemplaryembodiment the flexible filament body is formed from a #2 filament(about 23 gauge to about 24 gauge), such as an Orthocord™ filament thatis commercially available from DePuy Mitek, Inc. or an Ethibond™filament that is commercially available from Ethicon, Inc., Route 22West, Somerville, N.J. 08876. Orthocord™ suture is approximatelyfifty-five to sixty-five percent PDS™ polydioxanone, which isbioabsorbable, and the remaining thirty-five to forty-five percent ultrahigh molecular weight polyethylene, while Ethibond™ suture is primarilyhigh strength polyester. The amount and type of bioabsorbable material,if any, utilized in the filaments of the present disclosure is primarilya matter of surgeon preference for the particular surgical procedure tobe performed.

The type, size, and strength of the materials used to form the suturefilament or repair construct can likewise depend, at least in part, onthe materials and configuration of the flexible filament body, the typeof bone or tissue with which it will be used, and the type of procedurewith which it will be used. In one exemplary embodiment the flexiblematerial is a #2 filament (about 23 gauge to about 24 gauge), such as anOrthocord™ filament that is commercially available from DePuy Mitek, Incor Ethibond™ filament available from Ethicon, Inc. Generally thefilament is relatively thin to minimize any trauma to tissue throughwhich it passes. In some embodiments the filament can have a sizebetween about a #5 filament (about 20 gauge to about 21 gauge) and abouta #5-0 filament (about 35 gauge to about 38 gauge). The Orthocord™ #2filament can be useful because it has a braided configuration, whichallows other components, including the filament itself, to pass throughsubcomponents of the braid without causing damage to the filament.Filaments configured to allow for a cannulated configuration, such as byremoving a core therefrom or having a pre-formed cannulatedconfiguration, can also be used. Orthocord™ suture is approximatelyfifty-five to sixty-five percent PDS™ polydioxanone, which isbioabsorbable, and the remaining thirty-five to forty-five percent ultrahigh molecular weight polyethylene, while Ethibond™ suture is primarilyhigh strength polyester. The amount and type of bioabsorbable material,if any, utilized in the filament bodies and the repair constructs of thepresent disclosure is primarily a matter of surgeon preference for theparticular surgical procedure to be performed.

In addition to providing implants that can be less traumatic to tissue,and reduces an amount of bone removed to form a bone tunnel, the presentdisclosures also provide for embodiments that make it easier for asurgeon to identify a location of an implant during a surgicalprocedure. These embodiments come in a variety of forms, and one suchembodiment is illustrated in FIGS. 13-14D.

As shown in FIG. 13, a feedback unit 492 is provided to assist a surgeonin knowing a location of an implant 420. The feedback unit 492 is apliable body 494, sometimes referred to as a pledget, that includes amidpline 496 disposed approximately at a midpoint along its length 1. Inother embodiments, the midpline 496 can be a hinge. Opposed plates 498a, 498 b of the body 494 can rotate about the midpline 496 between astraight and a bent configuration. More particularly, the plates 498 a,498 b pledget 494 can be biased towards the straight configuration, butthey can be configured to move to the bent configuration by applyingsufficient pressure to the pledget 494, for instance by applyingpressure to ends of the pledget 494 when it passes through a smallspace. The pledget 494 can be disposed within a flexible filament body,as shown, or in other embodiments it can be attached to an outer surfaceof the body 440 of the implant 420. In some embodiments, a filament tail450 can be passed through openings 446 of the flexible filament body 440and openings 499 formed through both plates 498 a, 498 b of the pledget494, to be used to direct positioning of the flexible body 440, and thusthe pledget 494, during a surgical procedure.

In use, the flexible filament body 440 can have a suture filament orrepair construct 460 formed into coils 462 a, 462 b associated therewithto form the implant 420, with a graft 490 (only shown in FIG. 14A)disposed within openings 464 a, 464 b of the coils, and thus associatedwith the body 440, as shown in FIG. 14A. The implant 420 can be drawnthrough a bone tunnel 2100, e.g., a femoral tunnel, as shown the tunnel2100 having both an implant-passing tunnel 2102 and a graft tunnel 2106,by applying tension to the filament tail 450 approximately in adirection G. The tunnel 2100 and pledget 494 can be sized such that asthe flexible body 440 is passed through the graft tunnel 2106, thepledget 494 remains in the straight configuration, illustrated in FIGS.14A and 14B, and when the body 440 passes into the implant-passingtunnel 2102, the pledget 494 moves into its bent configuration, as shownin FIG. 14C. When the pledget 494 exits the implant-passing tunnel 2102,it returns back to the straight configuration in view of the bias of thepledget 494, as shown in FIG. 14D. As the pledget 494 returns to thestraight configuration, it can make an audible sound, thereby notifyinga surgeon of the configuration change. When a surgeon hears this sound,the surgeon knows that the flexible filament body 440 has passed throughimplant-passing tunnel 2102, and thus the flexible filament body 440 canbe actuated into the anchoring configuration as desired. In someinstances, a surgeon may also feel the pledget 494 return to thestraight configuration, for instance in the form of a tactile “click,”thus providing an alternative notification that the flexible filamentbody 440 has passed through the implant-passing tunnel 2102, referred toherein as tactile feedback.

FIGS. 15A-16E provide for alternative feedback units 592, 592′, 592″,592′″, 592″″ for use with implants 520, 520′, 520″ (implants 520′″,520″″ for use with the feedback units of FIGS. 15D and 15E are notillustrated). The feedback units 592, 592′, 592″, 592′″, 592″″ in thesefigures are bodies or pledgets 594, 594′, 594″, 594′″, 594″″ designed tobe disposed at a terminal end of a flexible filament body 540, 540′,540″ (flexible filament bodies 540′″, 540″″ for use with the feedbackunits 592″, 592″″ of FIGS. 15D and 15E are not illustrated). Such aconfiguration can be helpful for configurations of flexible filamentbodies 540, 540′, 540″ having leading tails 550, 550′, 550″ disposed atterminal ends 540 b, 540 b′, 540 b″. The bodies 594, 594′, 594″, 594′″,594″″ can be pliable such that in a resting configuration a greatestwidth w₁, w₂, w₃, w₄, w₅ thereof is larger than a diameter of animplant-passing tunnel, but the bodies 594, 594′, 594″, 594′″, 594″″ canbe compressed to pass through such a tunnel when tension is applied tothe bodies, thus placing the bodies into a compressing configuration.The bodies 594, 594′, 594″, 594′″, 594″″ can have any number of shapes,five of which are illustrated in FIGS. 15A-15E. In the embodiments ofFIGS. 15A-15C, the feedback unit 594, 594′, 594″ is disposed at adistal, terminal end 540 a, 540 a′, 540 a″ of the flexible filament body540, 540′, 540″, while the embodiments of FIGS. 15D and 15E are alsoconfigured to be disposed at a distal, terminal end of a flexiblefilament body, although the feedback units 594′″, 594″″ are illustratedby themselves in the figures.

The body 594 in FIG. 15A is shaped like an elliptical shim, the body594′ in FIG. 15B is shaped like a hoop that includes an opening 595′,the body 594″ in FIG. 15C is shaped like a circular disk or puck, thebody 594′″ in FIG. 15D is shaped like an elliptical button, and the body594″″ in FIG. 15E is shaped like an hourglass. The bodies 594, 594′,594″, 594′″, 594″″ can be attached to the flexible filament bodies 540,540′, 540″ (flexible filament bodies 540′″, 540″″ for use with thefeedback units 592″, 592″″ of FIGS. 15D and 15E are not illustrated)using any techniques known to those skilled in the art. By way ofnon-limiting examples, a connecting filament 552, 552″ connects thebodies 594, 594″ to the flexible filament bodies 540, 540″ in FIGS. 15Aand 15C, and the body 594′ is passed through the flexible filament body540′ in FIG. 15B. The bodies 594, 594′, 594″, 594′″, 594″″ are generallykept adjacent to the terminal end 540 b, 540 b′, 540 b″ (terminal ends540 b′″, 540 b″″ for use with the feedback units 592″, 592″″ of FIGS.15D and 15E are not illustrated) to provide for accurate notificationthat the flexible filament body has passed through a bone tunnel, asdescribed below. Similar to the pledget 494, the notification orfeedback provided by the bodies 594, 594′, 594″, 594′″, 594″″ can beaudible and/or tactile.

FIGS. 16A-16E illustrate the implant 520 being used in an implantprocedure in which the implant 520 is passed through a bone tunnel2100′, e.g., a femoral tunnel, the tunnel 2100′ including animplant-passing tunnel 2102′ and a graft tunnel 2106′. As shown, theimplant 520 that includes the flexible filament body 540 and body 594 ofthe feedback unit 592, also includes a suture filament or repairconstruct 560 and a graft 590 passed through openings 564 a, 564 bformed by coils or loops 562 a, 562 b of the repair construct 560. Theflexible filament body 540 includes the leading tail 550, and the repairconstruct 560 includes a slidable portion 570 disposed on a first side542 of the body 540 having closure or tensioning limbs 580, 582extending therefrom. A majority of a portion of the coils 562 a, 562 bare disposed on a second side 544 of the body 540.

The implant 520 can be drawn into the graft tunnel 2106′ and theimplant-passing tunnel 2102′ by applying tension to the leading endapproximately in a direction G′ as illustrated in FIG. 16A. The tunnels2102′, 2106′ and body 594 can be sized such that as the body 594 ispassed through the graft tunnel 2106′, the body 594 remains in theresting configuration, illustrated in FIGS. 16A and 16B, and when itpasses into the implant-passing tunnel 2102′, it moves into itscompressing configuration, as shown in FIG. 16C. When the body 594 exitsthe implant-passing tunnel 2102′, it returns back to the restingconfiguration, a shown in FIG. 16D. As the body 594 returns to theresting configuration, it can make an audible sound, thereby notifying asurgeon of the configuration change. When a surgeon hears this sound,the surgeon knows that the flexible filament body 540 has passed throughimplant-passing tunnel 2102′, and thus the flexible filament body 540can be actuated into the anchoring configuration as desired, illustratedin FIG. 16E. Actuation of the flexible filament body 540 can beinitiated using any of the techniques described herein, including byapplying tension to the coils 562 a, 562 b in a direction away from thebody 540, as shown by applying tension approximately in a direction C″″.

In this embodiment, the feedback unit 592 ends being disposed betweenthe bone and the flexible filament body 540. As the flexible filamentbody 540 is actuated, it can apply a force on the body 594 of thefeedback unit 592 approximately in a direction H′ to help maintain thebody 540 at a location adjacent to the bone tunnel, and thus the suturefilament 560 within the bone tunnels 2102′, 2106′. Further, oradditionally, a surgeon may also feel the body 594 return to the restingconfiguration, thus providing an alternative notification that theflexible filament body 540 has passed through the implant-passing tunnel2102′.

FIGS. 17-18E illustrate another alternative feedback unit 692 for usewith an implant 620. The feedback unit 692 described is a measuring tail694 that extends from a terminal end 640 b of a flexible filament body640 of the implant 620. The measuring tail 694 includes markings 697along its length l_(T) that denote the distance each marking of themarkings 697 is from the terminal end 640 b of the flexible filamentbody 640. The inclusion of the measuring tail 694 at the terminal end640 b can be particularly useful for embodiments in which an opposedterminal end 640 a includes a leading tail 650. The measuring tail 694can be flexible such that it can easily pass through a bone tunnel2100″, e.g., a femoral tunnel, including both an implant passing tunnel2102″ and a graft tunnel 2106″ (FIGS. 18A-18E), and it can be made fromthe same filament that forms the flexible filament body 640, or it canbe a different filament or other flexible material. The length l_(T) ofthe measuring tail 694 is typically at least as long as a length of theimplant-passing tunnel 2102″ so that way the tail 694 can help provideinformation to the surgeon about whether the flexible filament body 640has passed through the implant-passing tunnel 2102″, as described below.A width of the measuring tail 694 can be such that it is skinny enoughto be able to pass through the implant-passing tunnel 2102″. In theillustrated embodiment, the measuring tail is approximately 20millimeters long and includes markings 697 on a surface thereof in 5millimeter increments, starting from 0 millimeters and going to 20millimeters. Any number and increment of markings 697 can be used. Insome embodiments, the tail 694 can be color coded or include othervisualization features that help make it easier for a surgeon to see themarkings on the body.

In use, the implant 620 can include the flexible filament body 640 and asuture filament or repair construct 660 associated with the body 640 andformed into coils 662 a, 662 b. A graft 690 can be disposed withinopenings 664 a, 664 b of the coils 662 a, 662 b, and thus associatedwith the body 640, as shown in FIG. 18A. The flexible filament body 640includes the leading tail 650, and the suture filament 660 includes aslidable portion 670 disposed on a first side 642 of the body 640 havingclosure limbs or tensioning tails 680, 682 extending therefrom, and amajority of the coils 662 a, 662 b are disposed on a second side 644 ofthe body 640. Prior to implantation, a length of the implant-passingtunnel 2102″ of the bone tunnel 2100″ can be measured, and the measuredlength marked on the measuring tail 694.

The implant 620 can be drawn into the graft tunnel 2106″ and theimplant-passing tunnel 2102″ by applying tension to the leading endapproximately in a direction G″ as illustrated in FIG. 18A. A length ofthe implant-tunnel 2102″ can be less than or equal to the length l_(T)of the measuring tail 694. The flexible filament body 640 then passesthrough the graft tunnel 2106″, as shown in FIG. 18B, and into theimplant-passing tunnel 2102″, as shown in FIG. 18C. In the illustratedembodiment, as the terminal end 640 a of the flexible filament body 640exits the implant-passing tunnel 2102″, the measuring tail 694 begins toenter the graft-passing tunnel 2106″. As shown in FIG. 18D, avisualization device 2200, such as an endoscope, can be placed proximateto a distal end of the implant-passing tunnel 2102″ to allow a user towatch when the marked location on the measuring tail 694, which denotesthe length of the implant-passing tunnel 2102″, enters theimplant-passing tunnel 2102″. When that marked location enters theimplant-passing tunnel 2102″, a user also knows that the flexiblefilament body 640 is fully exiting the implant-passing tunnel 2102″.After the flexible filament body 640 has fully exited theimplant-passing tunnel 2102″, or even before it has fully exited in someinstances, the body 640 can be actuated into the anchoringconfiguration, as shown in FIG. 18E, using techniques already discussedherein, including by applying tension to the coils 662 a, 662 b in adirection away from the body 640, as shown by applying tensionapproximately in a direction C′″″. Further, a person skilled in the artwill recognize that other locations can be marked on the marking tail694, and the timing of when different portions of the implant 620, thefeedback unit 692, and/or the graft 690 enter and exit portions of thebone tunnel 2100″ can be changed and adjusted as desired withoutdeparting from the spirit of the present disclosure.

FIGS. 19A-20E illustrate still another alternative feedback unit 792 foruse with an implant 720. The feedback unit 792 is a rigid body 794having a length l_(B) that is larger than a diameter of animplant-passing tunnel 2102′″ so that the unit 792 cannot pass into theimplant-passing tunnel 2102′″. The rigid body 794 can have any number ofshapes, similar to the pledgets 594 of FIGS. 15A-15E, but in theillustrated embodiment the body 794 is a disk or puck shape. As shown inFIGS. 19A and 19B, the body 794 is attached to a flexible filament body740 of the implant 720 using a connecting filament 752, and a lengthl_(C) of the connecting filament 752 is as long as, or slightly longer,than a length of the implant-passing tunnel 2102′″. As a result, thebody 794 can engage bone proximate to a distal end of theimplant-passing tunnel 2102′″ while the flexible filament body 740 canexit a proximal end of the implant-passing tunnel 2102′″, and theconnecting filament 752 extending therebetween remains disposed in theimplant-passing tunnel 2102′″. Engagement of the bone proximate to thedistal end of the implant-passing tunnel 2102′″ provides both audibleand tactile feedback to the user.

FIG. 19B illustrates that the implant 720 can also include a suturefilament or repair construct 760 associated with the flexible filamentbody 740 using techniques provided for herein or otherwise known tothose skilled in the art. In the illustrated embodiment, the repairconstruct 760 includes coils 762 a, 762 b that extend freely from theflexible filament body 740 and are not coupled with or directlyassociated with the body 740. In other embodiments, one or more portionsof the repair construct 760 can be passed through the body 740. Further,a leading tail 750 can also be associated with the flexible filamentbody 740, and a graft 790 can be disposed within openings 764 a, 764 bof the coils 762 a, 762 b, as shown in FIGS. 20A-20E. The repairconstruct 760 can also include a slidable portion 770 disposed on afirst side 742 of the body 740 having closure limbs or tensioning tails780, 782 extending therefrom, and a majority of the coils 762 a, 762 bcan be disposed on a second side 744 of the body 740.

In use, the implant 720 can be drawn into a bone tunnel 2100′″ havingboth an implant-passing tunnel 2102′″ and a graft tunnel 2106′″ byapplying tension to the leading tail 750 approximately in a directionG′″ as illustrated in FIG. 20A. The flexible filament body 740 thenpasses through the graft tunnel 2106′″ and into the implant-passingtunnel 2102′″, as shown in FIG. 20B. As a terminal end 740 a of theflexible filament body 740 approaches the proximal end of theimplant-passing tunnel 2102′″, the body 794 engages bone surrounding adistal end of the implant-passing tunnel 2102′″. As shown in FIG. 20C,in embodiments in which the repair construct 760 is not passed throughthe body 794, the repair construct 760 can wrap around an outerperimeter of the body 794 as it passes from one side 742 of the body 740to the opposite side 744, and into the graft tunnel 2106′″. Thus, thebody 794 may engage the bone directly, or it may have a repair construct760 disposed therebetween. The body 794 can have a smooth surface toprevent the body 794 from undesirably cutting or causing the repairconstruct 760 to fray when the repair construct 760 is pinched betweenthe body 794 and the bone. In alternative embodiments, the repairconstruct 760 can pass through the body 794, in which case the body 794can directly engage the bone.

Further application of tension to the leading tail 750 approximately inthe direction G′″ can pull any remaining portion of the flexiblefilament body 740 out of the implant-passing tunnel 2102′″, as shown inFIG. 20D. The body 794 remains disposed at the distal end of theimplant-passing tunnel 2102′″ because the body 794 remains engaged withthe bone. Likewise, the repair construct 760 remains disposed in boththe implant-passing and graft tunnels 2102′″, 2106′″, and the graft 790remains below the implant-passing tunnel 2102′″, because the body 794prevents further advancement through the tunnel 2102′″. Similar to otherembodiments, the flexible filament body 740 can then be actuated, asshown in FIG. 20E, to set the location of the flexible filament body 740with respect to bone when the body 740 is in the anchoringconfiguration. Actuation can be performed using techniques alreadydiscussed herein, including by applying tension to the coils 762 a, 762b in a direction away from the body 740, as shown by applying tensionapproximately in a direction C″″″. The repair construct 760 can bemanipulated to decrease a size of the openings 764 a, 764 b of the coils762 a, 762 b to pull the graft 790 into, or further into, the grafttunnel 2106′″, using techniques provided for herein or otherwise knownto those skilled in the art. As shown in FIG. 20E, the graft 790 can bepulled up to the body 794 while the flexible filament body 740 isanchored with respect to the tunnel 2100′″ at the proximal end of theimplant-passing tunnel 2102′″.

Exemplary size and shapes of the various embodiments of feedback unitscan depend on a variety of factors, including but not limited to thesizes and shapes of the other components with which it is used (e.g.,the implants, flexible filament bodies, repair constructs, grafts), thetype of procedure being performed, and preferences of the user. In someexemplary embodiments, a material used to form the bodies 494, 594,594′, 594″, 594′″, 594″″, 694, and 794 includes but is not limited tobiocompatible materials, polymers, plastics, polyetheretherketone(PEEK), ultra high molecular weight polyethylene, and polypropylene.More than one of these materials can be used to form a feedback unit.

FIGS. 21A-21C illustrate one exemplary embodiment for forming a tunnel101′ (FIG. 21C), e.g., a femoral tunnel, in bone 100′ through whichimplants of the nature provided for herein, or otherwise derivable fromthe disclosures herein, can be used. The bone 100′ in which the tunnel101′ is to be formed is illustrated in FIG. 21A. The procedure begins byusing a Beath pin to form a tunnel 102′ through an entire thickness ofthe bone 100′, as shown in FIG. 21B, the tunnel 102′ having a diameterapproximately in the range of about 2 millimeters to about 2.5millimeters. The Beath pin, which is typically thin and long, can remaindisposed within the bone tunnel 102′ to act as a guidewire to helpposition additional tools for drilling the portion of the tunnel 101′having a larger diameter.

More particularly, a reamer can be passed over the Beath pin from adistal end of the bone 100 d′ to form a larger portion of the tunnel101′, shown in FIG. 21C. A diameter of the larger portion can be basedon the size of the graft(s) to be disposed therein, and can beapproximately in the range of about 6 millimeters to about 8millimeters. As described above, the first, proximal portion 102′ of thetunnel 101′ illustrated in FIG. 21C serves as the implant-passingtunnel, and the second, distal portion of the tunnel 106′ illustrated inFIG. 21C serves as the graft tunnel. In comparison to the method offorming bone tunnels 101 described with respect to FIGS. 1A-1D, themethods provided for as described with respect to FIGS. 21A-21Celiminate a drilling step and remove less bone because no expansion ofthe top portion of the tunnel is required in view of the implants andmethods disclosed herein.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. For example,to the extent the present disclosure disclose using the devices andmethods provided for herein for ACL repairs and/or within a femoraltunnel, a person skilled in the art will recognize how the presentdisclosures can be adapted for use with other anatomies. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A surgical method, comprising: loading a graftonto one or more coils of a suture filament that is coupled to aflexible filament body, the flexible filament body having a shuttlefilament extending therefrom; pulling the shuttle filament, and thus theflexible filament body, the suture filament, and the graft, through abone tunnel until the flexible filament body is pulled out of the tunnelwhile at least a portion of the suture filament and the graft remain inthe tunnel; and collapsing the flexible filament body to draw terminalends of the body that define a length of the body closer together andplace the flexible filament body in an anchored configuration in whichthe flexible filament body is disposed on one side of the bone tunneland the graft is disposed on an opposite side of the bone tunnel.
 2. Themethod of claim 1, wherein collapsing the flexible filament body furthercomprises applying tension to the one or more coils in a direction awayfrom the flexible filament body to cause the flexible filament body tocollapse.
 3. The method of claim 1, wherein the suture filament has aslidable portion formed therefrom and a tensioning tail extends from theslidable portion, the method further comprising: applying tension to thetensioning tail to adjust a circumference of one or more coils of thesuture filament.
 4. The method of claim 1, wherein when the flexiblefilament body is pulled out of the tunnel, at least one of an audiblesound and tactile feedback is generated by a feedback unit associatedwith the flexible filament body to notify a user that the flexiblefilament body has passed through the tunnel.
 5. The method of claim 4,wherein the feedback unit is disposed in a portion of the flexiblefilament body.
 6. The method of claim 4, wherein the feedback unit iscoupled to a terminal end of the flexible filament body.